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Chlorhexidine Topical (Periogard) Package Insert

Status:
Prescription (Rx) Facts
Strength:
4 g/100 mL
Active ingredient:

Prescribing information (package insert) - Chlorhexidine Topical

Active Ingredient

Chlorhexidine gluconate 4% Solution

Purpose

Antiseptic

Uses

  • healthcare personnel handwash: helps reduce bacteria that potentially can cause disease
  • skin wound and general skin cleansing

Warnings

For external use only

Allergy alert:

This product may cause a severe allergic reaction. Symptoms may include:

  • wheezing/difficulty breathing
  • shock
  • facial swelling
  • hives
  • rash

If an allergic reaction occurs, stop use and seek medical help right away.

Do not use

  • if you or the patient is allergic to chlorhexidine gluconate or any other ingredient in this product
  • in contact with meninges
  • in the genital area

When using this product

  • keep out of eyes, ears, and mouth. May cause serious and permanent eye injury if permitted to enter and remain in the eye or may cause deafness when instilled in the middle ear through perforated eardrums.
  • if solution should contact these areas, rinse out promptly and thoroughly with water
  • wounds which involve more than the superficial layers of the skin should not be routinely treated
  • repeated general skin cleansing of large body areas should not be done except when advised by a health care provider.

Stop use and ask a doctor if

irritation, sensitization or allergic reaction occurs. These may be signs of a serious condition.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • use with care in premature infants or infants under 2 months of age. These products may cause irritation or chemical burns.

Healthcare personnel handwash:

  • wet hands with water
  • dispense about 5 mL of product into cupped hands and wash in a vigorous manner for about 15 seconds
  • rinse and dry thoroughly

Skin wound and general skin cleansing:

  • throughly rinse the area to be cleaned with water
  • apply the minimum amount of product necessary to cover the skin or wound area and wash gently
  • rinse again thoroughly

Other information

  • store at 20-25ºC (68-77ºF)
  • avoid excessive heat above 40ºC (104ºF)

Inactive ingredients

cocamide DEA, fragrance, glucono-delta-lactone, hydroxyethylcellulose, isopropyl alcohol, lauramine oxide, PEG-75 lanolin, purified water, tridecyl alcohol.

Questions or comments?

1-800-587-3721

Warning: This product can expose you to coconut oil diethanolamine condensate (cocamide diethanolamine), which is known to the State of California to cause cancer. For more information fo to www.P65Warnings.ca.gov.

Laundering/Cleaning Instructions: Chlorhexidine gluconate skin cleansers will cause stains if used with chlorine releasing products. Rinse completely and use only non-chlorine detergents.

*This product is not manufactured or distributed by Mölnlycke Healthcare, owner of the registered trademark Hibiclens®.

Indications and Usage

Dosage and Administration

Directions (12/14)

uses

About this document

Source: FDA drug labeling via NLM DailyMed · Application number: NDA 019125 · View the label on DailyMed

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The information on this site does not replace the advice of a doctor or pharmacist.

Drug information for Chlorhexidine Topical

Rx or OTC
Prescription (Rx)?
  • This drug is available only with a prescription from a licensed healthcare provider.
  • Rx
Active ingredient Chlorhexidine gluconate 4 g/100 mL
Dosage form Solution
Route Topical
Marketing status listed in the FDA NDC Directory
Company (applicant) XTTRIUM
FDA approval NDA 019125New Drug Application (NDA) Approved December 24, 1984
Manufacturers 1 labelers list this drug on DailyMed
Packages (NDC)
Package
4 g/100 mL – 237 ml in 1 bottle, plastic NDC 0116-0407-01

Source: FDA drug labeling via NLM DailyMed, data as of October 31, 2026. FDA data (DailyMed, Orange Book, Drug Shortages, enforcement reports). Not a substitute for the advice of a doctor or pharmacist.